RadioMedix SPICA Center, a state-of-the-art facility provides contract development and manufacturing services for radiopharmaceutical companies, as well as products in its own pipeline. The company expects rapid growth and is looking for an experienced radiopharmacist to support and lead production activities. This key leadership position is a “hands-on” role that will interface with various functions at RadioMedix and collaborators to ensure timely, cost-effective development and manufacturing of radiopharmaceutical diagnostics and therapies for clinical supply and commercial launch.

Principal Responsibilities are:

Oversee the execution of the organization’s contract manufacturing, outsourcing and/or in-sourcing relationships and opportunities
Oversee capabilities for the company’s developmental candidates and the commercial product production
Lead in-house and outsourced activities to develop and optimize processes for RadioMedix’s novel therapeutics or imaging agents
Lead outsourced development and manufacturing activities for small molecule active pharmaceutical ingredients and/or precursors used in radiopharmaceutical products
Responsible for production planning and managing supply chain
Assist in SOP development, implementation, and revision
Formulating and recommending manufacturing policies and programs
Support the Quality Assurance unit during regulatory inspections
Hire, supervise, and train new production staff, as needed
Establish contract manufacturing partnerships with potential clients and manage tech transfer
GMP manufacturing for clinical drug supply
Technical writing and review of CMC related regulatory documents, SOPs, Quality Events, RFPs, etc
Support other projects as needed
Identify manufacturing and testing facilities for radiopharmaceuticals.

Qualifications Required:

Education: Ph.D., Radiopharmacist

Experience: Candidates should have a minimum of 7-10 years relevant work experience.

Knowledge and experience in the following areas:

Attentiveness to detail; strong communication and coaching skills; team-oriented focus; strong planning and organizational skills
Manufacturing operations under cGMP compliance, aseptic processing, protein purification, process engineering, validation, technical writing, operations and maintenance of utility systems
Experience with lutetium, Ga-68, alpha emitters radiopharmaceutical isotopes is highly desirable
Ability to properly assess resources and plan accordingly
Willing to travel when needed

Qualifications Required:

1. Bachelors degree in chemistry with a minimum of 2 years of experience with organic synthesis of compounds or analytical chemistry. Priority given to candidates with experience with the production and quality control of Ga-68, Lu-177, Cu-64, Ac-225, and Pb-212 radiopharmaceuticals.

2. Experience with quality control for identity and quantitation using various instruments such as High Performance Liquid Chromatography (HPLC), Thin Layer Chromatography (TLC), Liquid Chromatography/mass spectrometry (LCMS), gas chromatography (GC), and Limulus test for apyrogenicity. Experience with ICPMS is a plus.

3. Knowledge of safety procedures for working in a hazardous environment (chemical and radiological) as demonstrated through prior laboratory experience.

4. Knowledge of cGMP requirements, aseptic process (cleanroom environment), and equipment qualification required.

5. Knowledge of gamma spectroscopy, alpha spectroscopy, liquid scintillation instrumentation.

6. Understands chemistry manufacturing and controls (CMC) documentation for novel compounds consistent with requirements for IND, NDA, ANDA, or other regulatory pathways.

Duties and Responsibilities:

1. The Radiochemist will be involved in the Quality Control section of RadioMedix manufacturing site.

2. Perform Quality Control tests according to SOPs on radiopharmaceutical products (e.g. TLC, GC, sterility, bioburden, HPLC).

3. Perform release testing according to SOPs on other materials (e.g. raw materials for radiopharmaceutical production).

5. Maintain accurate radiopharmaceutical production records and test/validation results.

Technical Skills Required:

1.Working knowledge of organic and analytical chemistry.

2. Working knowledge of radiochemistry.

3. Experience with automated equipment for synthesis and purification is preferred but not required.

4. Ability to work independently and in a team with strong communication skills, including proficiency in English both written and oral.

5. Demonstrated ability to prioritize multitask and troubleshoot problems.

6. Demonstrated ability to readily acquire new skills and techniques.

Career Opportunities

Current Opportunities

Principal Responsibilities are:

Qualifications Required:

Knowledge and experience in the following areas: